Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202310681115588 Date of Approval: 16/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of music therapy on pain and anxiety during third molar surgery
Official scientific title Effect of music therapy on pain and anxiety during third molar surgery
Brief summary describing the background and objectives of the trial Music therapy has been used with promising results to reduce pain and anxiety in surgical specialties such as orthopaedic, obstetrics and general surgery. As observed in other specialties, music is suggested to reduce anxiety and pain perception during dental surgeries with the potential to improve clinical outcomes. Aim: The aim of this study is to determine whether listening to music during trans-alveolar mandibular third molar extraction modulates pain perception and anxiety
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/09/2019
Actual trial start date 01/09/2019
Anticipated date of last follow up 01/09/2020
Actual Last follow-up date 04/12/2020
Anticipated target sample size (number of participants) 146
Actual target sample size (number of participants) 146
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
UIEC180569 INSTITUTE OF ADVANCED MEDICAL RESEARCH AND TRAINING, COLLEGE OF MEDICINE, UNIVERSITY OF IBADAN, NIGERIA
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Music therapy Started before surgery and lasted till the end of surgery Patient-specific choices of music administered for surgery. The participants were required to provide a list of music by genres, artiste etc that make them relax 73
Control Group Nonmusic Not applicable No music was administered during surgery 73 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients with impacted mandibular third molar indicated for removal with Pederson Difficulty Index of 6 and below. 2. Patients with no history of hearing impairment or ear disease. 3. Patients who can tolerate use of headphones. 4. Patients who do not present with acute pain. 5. Patients with active mobile phones. 1. Patients with medically compromised state such as uncontrolled diabetes and hypertension 2. Patients with known allergy to local anesthetic 3. Patients with medical history of cognitive impairment such as delirium, amnesia, dementia 4. Patients whose procedure last more than one hour from the first incision to closure. 5. Patients in whom local anesthesia cannot be achieved 6. Patients without a functional active phone 7. Patients with history of peptic ulcer disease 8. Patients who do not like to listen to music 9. Impacted molars with Pederson Difficulty Index of 7 and above 10. Patients who declined participation in the study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 55 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/12/2017 UIUCH ETHICS COMMITTEE INSTITUTE OF ADVANCED MEDICAL RESEARCH AND TRAINING COLLEGE OF MEDICINE UNIVERSITY OF IBADAN NIGERIA
Ethics Committee Address
Street address City Postal code Country
QUEEN ELIZABETH ROAD IBADAN NIGERIA IBADAN 200212 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/11/2018 UIUCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
COLLEGE OF MEDICINE, UNIVERSITY OF IBADAN, QUEEN ELIZABETH ROAD IBADAN NIGERIA IBADAN 200212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain intensity one minute after informed consent, after disto-buccal guttering, after tooth delivery and one minute after the last stitch. Post-operative pain scores at 1-hour, 3-hour, 6-hour, 24-hour and 48-hour
Secondary Outcome Anxiety Immediately after informed consent and one minute after last stitch
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Queen Elizabeth Road Ibadan Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SELF FUNDED C22 OLUBADAN ESTATE NEW IFE ROAD IBADAN Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor OLUSEGUN OLAOPA C 22 OLUBADAN ESTATE NEW IFE ROAD IBADAN Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
PROFESSOR AO FASOLA QUEEN ELIZABETH ROAD IBADAN Nigeria
DR OO GBOLAHAN QUEEN ELIZABETH ROAD IBADAN Nigeria
DR AA OLUSANYA QUEEN ELIZABETH ROAD IBADAN Nigeria
PROFESSOR JT AROTIBA QUEEN ELIZABETH ROAD IBADAN Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator OLUSEGUN OLAOPA segunolaopa@gmail.com +2348023653264 OLUBADAN ESTATE ROAD C
City Postal code Country Position/Affiliation
IBADAN Nigeria CONSULTANT ORAL AND MAXILLOFACIAL SURGEON FEDERAL MEDICAL CENTRE LAGOS
Role Name Email Phone Street address
Public Enquiries FAVOR IGBINAZAKA favoursailing@yahoo.com +2348169606712 QUEEN ELIZABETH ROAD
City Postal code Country Position/Affiliation
IBADAN Nigeria SENIOR REGISTRAR UNIVERSITY COLLEGE HOSPITAL IBADAN NIGERIA
Role Name Email Phone Street address
Scientific Enquiries JUWON AROTIBA juwonarotiba@yahoo.com +2348023339579 QUEEN ELIZABETH ROAD
City Postal code Country Position/Affiliation
IBADAN Nigeria PROFESSOR UNIVERSITY OF IBADAN NIGERIA
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1. Will individual participant data be available (including data dictionaries)? YES. The may be provided upon request 2. What data in particular will be shared? Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) 3.What other documents will be available? No other document is available 4.When will data be available (start and end date)? The data has already been completed upon conclusion of my dissertation. The data is available and may be provided Immediately following publication, No end date 5.With who? Limited data may be provided to anyone who wishes to access the data 6.For what types of analyses? To achieve aims in the approved proposal 7.By what mechanism will date be made available? Not applicable Informed Consent Form Immediately following publication, No end date OPEN ACCESS THIRD PARTY REQUESTS
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 02/10/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 02/10/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks Not applicable
Changes to trial information